PRAVARA RURAL COLLEGE

PHARMACY PRAVARANAGAR
INDUSTRIAL TRAINING REPORT

ACADEMIC YEAR: 2021-22

FOR PARTIAL FULFILMENT OF
B.PHARMACY
VIIth SEMESTER
Submitted By: Mr.Chavan Saurav Rajendra.
Under the Guidance of
Dr. Sanjay B. Bhawar (Principal, PRCOP)
Prof. Someshwar Mankar (TP Cell, PRCOP)
 AKNOWLEDGEMENT
In the Accomplishment of completion of my Report on
Industrial Training I would like to convey special gratitude and thanks
to Prof. Mr. S.D.Mankar of Training and Placement Department as
well as Dr. Sanjay B. Bhawar Principal of Pravara Rural College of
Pharmacy, Pravaranagar.

I would like to extend my deep appreciation to Mr.Sumedh

Gangavne Sir (HR department) for providing us this great
opportunity, without their support and coordination I would not have
been able to complete this Internship.

Your valuable guidance and suggestions helped me in various phases

of the training and completion of this report.

I will always be thankful to all of you in this regard.

I am ensuring that this project was finished by me and not copied.

Name of student- Mr. Chavan Saurav Rajendra.

Email- sauravchavan721@gmail.com
Contact No: - 7040097115
 Certificate

This is to certify that project entitled report on industrial

training is submitted to Training and Placement cell, Pravara Rural
College of Pharmacy, Pravaranagar (SPPU) in the partial fulfillment
for the award of degree of Bachelor of Pharmacy by Mr. Chavan
Saurav Rajendra. Roll No:-08 at Concept Pharmaceuticals
Ltd.,Aurangabad.
All the content of this report is acknowledged and no part of this
report is submitted to elsewhere or copied.

Date:
Place:
 INDEX
Sr. Page
No. Content
No.
1. About
a) Objective
b) Plan Layout
2. Introduction To
formulations
3. Production Department
a)Processing Technologies
and Their Sequences.
b)List Of Pharmaceuticals

4. Quality Control Cell

a)Introduction and role of
QC
b) Instrumation
 c)Microbiology Department
5. Quality Assurance
a)Introduction
b)Documentation Process
6. Pilot Plant
7. Other Departments
a)Storage Area/ Warehouse
b)Production
c)Training and Placement
Cell.
  Concept was launched
as an independent
entity in 1984 by Shri A.
B. Gupta who had earlier
experience as founder
director of Lupin Group of
Companies for over 15 years.

Initially launched as a marketing company, but soon decided to strengthen the infrastructure to
keep up the pace and its ambitious objective in these 27 years it has emerged as strong multi-
divisional group with excellent infrastructure such as:

1) Pharmaceutical : Covering around 70% of the therapeutic groups.

2) Bulk Drugs Division : With 3 plants manufacturing Ampicillin sodium, Cephalexin,

Amoxycilium sodium, B2-5 phosphate, Nitrendipine, Roxithromycin, Fluconazole etc.

3) Generic & hospital division : Covering all major therapeutic groups and catering to all major
hospitals and institutions.

4) Medical electronics : Handling range of critical care products such as Cardiac Monitors,
Treadmills, Oximeters etc.

These activities are supported with a strong infrastructure such as 5 manufacturing plants, 21
branch offices – cum – distribution centers, more than 300 strong marketing force throughout
the country meeting 50,000 doctors every month supported by a network of around 1000
stockiest–cum–distributors. Company is putting lot of thrust towards R & D efforts and has
successfully launched few technologies, first time in the country through its own government
approved R&D centers. Concept Group of Companies also have received three Export awards
from the government and over a dozen awards from various organizations in recognition of its
achievements.

Plant Layout:
Introduction Phamaceutical Formulations:-
A pharmaceutical formulation is composed of several formulation
factors and process variables. Quantitative model-based
pharmaceutical formulation involves establishing mathematical
relations between the formulation variables and the resulting
responses and optimizing the formulation conditions. In a
formulation system involving several objectives, the desirable
formulation conditions for one property may not always be desirable
for other characteristics, thus leading to the problem of conflicting
objectives. Therefore, efficient modeling and optimization
techniques are needed to devise an optimal formulation system.

Production department:-
Manufacturing of Formulations is itself a complex procedure which
requires to fulfill stringent quality parameters and safety
considerations along with different fulfillments of regularity demands.
At the same time there is pressure to increase production efficiency.
Every plant is specified for particular drug production and this choice
is made according to ancillary utilities required for production. For
carrying out reaction for the production the large vessels called as
containers are required.

A)Containers(Reactor):
This are available in varying size but for production purposes
we mainly use 5KL to 20KL vessels. There are mainly two types of
container as follows-
Stainless steel grade vessels: For other than Acidic material.
Glass lined containers: Mainly for Acidic material.

B) Mixing/Blending:-
For mixing various mixing equipments like planetary mixer,V-cone
blender,Rotatory mixer are used to mix or blend the ingradients
according to particular size.
C) Drying:
For further processing of intermediate product it must be
free from mother liquor or solvent, this removal of moisture or
solvent is called as Drying. It includes application of heat, vacuum,
etc.
Fluidized bed dryer.
Vacuum tray dryer.
Tray dryer.
D)Packeging:-
For packeging of tablets and capsules high quality blister rolls
are used , for packeging of liquids glass or plastic containers
used according to need, for parentrals glass vials of
30,60,100,300,500ml are used.
The packeging material is taken from various local and other
vendors.

Documentation:
BMR- Batch Manufacturing Record.
The whole procedure of manufacturing of drug is documented
in BMR and is preserved. The steps are according to SOP and BMR is
the documented proof to that. The BMR is for single batch and is
consisting of signature record of personnel directly involved in
production, Head of production department, and other officials.

List of formulations Produced Anually:-

*Merocept
*Lafix 200 dt
*Sulfaprim
*Rifa i-6 kid
*Rifa i
*Losart
*Synclox
*Bovilox
*Rifa FD
*Lafix 200
*Lafix 50 dt
*Ibucon 200 plus tab.
*Ibucon 400 plus tab.
*Ibucon plus suspension
*Conflox
*Penlif cream
*Para kid
*Rifacept kid 3
*Rifacept 3
*Rifa i-6 kid tab.
*Rifa i-6 forte
*Rifa kit forte
*Rifa i-6 E
*Zincocept
*Ajar
*Hepacept
*Confit
*Hepacept tab.
*Clarex
*Artecon inj
*Oflab 100 dt
*Oflab 400
*Oflab 300
*Oflab 200
*Oflab suspension
*Oflab OZ tab
*Oflab OZ suspension.
*Lafix O
*Lafix 100 dt
*Flucream NM
*Ibucon plus kid
*Confit
Quality Control Cell:
Quality control (QC) is the department which actually
performs testing on Raw material, intermediates and final product.
They execute the chemical analysis of testing samples and compiled
the obtained data. It includes
set of measure and procedures in order to ensure that quality of
product is maintained and improved against a set of benchmarks and
errors encountered are either eliminated or reduced to acceptable
limit.
Quality control personnel receives samples from almost all forms of
products either as a raw material (from warehouse) or as finished
product (from storage area) or as intermediate product if necessary for
certain reactions. The sampling techniques are discussed under
context of Storage area of same report. The quality control department
is most engaged department of any Pharmaceutical industry. It’s
because the quality of final product cannot attain in any single step.
To get quality product at end of production cycle and to get stable
drug in period of its shelf life required quality parameters must be
fulfilled.
Objectives:
1) There is day to day control maintained over the quality aspect of
drug products.
2) Incoming raw materials goods and finished products are all tested
for compliance with predetermined quality specifications. 3)
Environmental monitoring is performed to make sure products are
manufactured, packed and stored under prescribed conditions.
Instrumentation:
Sr. Instrument Mech Software Application
No
.
1 UV Shimadzu Lab Quantitative and
Solutions Qualitative
Analysis.
UV-Vis
control Detection of
software Impurities and
Functional
groups
2 IR Shimadzu Lab Detection of
Solutions contaminants.
UV-Vis Identification of
control compounds.
software
Purity
calculations.
Functional
groups.
3 HPLC Shimadzu Empower3 Separation of a
complex mixture
of molecule ,
Analysis of
contaminants
and counterfeits
drug products.
4 GC Shimadzu and Empower3 Analysis of
Organic
(Headspace/ Agilant
compounds, high
technologies
Liquidspace) speed.
Detection of
solvents
component in
sample.
5 UPLC Waters Empower3 Operates at high
pressure, Cost
effective and
time efficient as
compared to
HPLC
6 Autotitrator Mettler Toledo LabX Analysis of
multiple raw
material and
finished
products.
7 Karl Fischer Mettler toledo LabX Estimation of
moisture content.
8 Polarimeter AutoPolV Spectra Detection of
manager Optical rotation
Rudolph research
of molecule.
Analytical
9 LCMS Alliance Mass lynx Determination of
residual
Column- Waters
chemical
Detector- Xero compounds.
TQD
Metabolism
studies and
product
characterisation.
Identification of
Impurities.
10 Milli-Q water Q-POD Element _ Highly purified
water for
Merk millipore
laboratory
analysis.

11 ICP-OES Perkin elmer WinLab Determination of

inorganic
(Inductively Model-
elemental
coupled Optima8300
impurities with
plasma
high precision
optical
emission
spectrometer)
12 Sieve Shaker Rotap & _
W.S. Tyler Particle Size
analysis
13 Tap density LabIndia _ Powder
characterisation
Electrolab
14 Weighing Mettler Toledo _ Measuring
 Balance samples

15 TLC CAMAG Win Cats Evaluation and

Visualizers visualization .

Microbiology Department-:
A microbiology laboratory plays an essential role in
pharmaceutical manufacturing and product release. It is responsible
for multiple task including-
 Investigating limits, specification, deviations and contamination
events.
 Evaluation, implementation and validation of QC methods and
testing are based upon results.
 Estimating limit of safe bioburden load and check either
product sample comply with it or not.
To meet the necessary standard of quality in efficient manner the
working personnel must be skillful and must work in compliance
with provided SOP’s.

Instrumentations:

Sr.no Instrument Mech Application

1 Autoclave Medica Sterilization of
equipment media,
instruments instruments,etc.
2 Steam pot Medica Digestion of
 equipments media
instruments
3 Laminar air flow Pharmatech Aseptic transfer
of media and
other products.
4 BOD Incubator Machpharma Provides
medium
Newtronic
environment for
Thermolab growth of
culture media.
5 Vitek-two Biomerics
6 Fogger machine - Sterilization of
working area.
7 pH meter Mettler toledo Measurement of
pH.

Quality Assurance Department:

 According to WHO the totality of arrangements made with the
object of ensuring that pharmaceutical product are of the quality
required for their intended use.
In the pharmaceutical industry, Quality assurance (QA) is essential
for ensuring that pharmaceutical products are manufactured to a safe
and consistent standard. QA is a very broad field that refers to any
aspect that may affect a drug's quality during its research,
development, manufacturing, and sales phases.
Quality assurance (QA) seeks to build quality into the product from
the very beginning of the process of drug manufacturing.
Objectives:

 QMS: (Quality management system) Regulates change control,

procedure, investigations.
OOS- Out of specifications.
OOT- Out of trend.
 Regulates batch release activity/ dispatched activity.
 Product design and development is in accordance with GMP,
GLP, GCP’S
 Vendor management.
 Validation activity (process, cleaning, analytical)
 Internal and external audit handling.(Audit compliance training)
 Annual product quality review.
 Market complaints.

Standard operating Procedures (SOP’s) Sample:

 Title: SOP for safety Procedures in laboratory.
Document No. Version and Effective Date Review due
status Date

SOP024386 2.0 and 28 Nov 2020 28 Nov 2023

effective

Signature Area
Name of Title Department Date Action
Personnel
(Position)
Mr.Rohit Senior Q.C. 10/10/2020 Approved
Patil Executive
Mrs.Varsha Senior Q.A. 12/10/2020 Approved
More Manager
Ms.Pranali General Q.A. 15/10/2020 Approved
Gaikawad Manager

 PURPOSE:
To Describe procedure for maintaining safety in working area.
 SCOPE:
This Procedure is applied to quality control laboratory in
manufacturing facility.
 RESPONSIBILITY:
 GMP Personnel-
Perform practices according to SOP’s.
Inform Supervisor in non –conformity.
Ensure to record all entries.
 Senior Executive-
Ensure the working personnel is well trained.
Implementation of SOP.
 Senior Manager-
Impart Training to personnel.
Ensure Implementation Perform Investigation in need.
Assessment.
 General Manager-
Review and ensure the SOP’s.
Manage Investigation.

5.0.Procedures
5.1. Guidelines for personal safety.
5.1.1. Eating/Smoking/Drinking in laboratory is
prohibited.
5.1.2. Use safety goggles for eye protection during handling of
corrosive/toxic/flammable material.
5.1.3. Wear lab coats and Gloves during handling of
corrosive/toxic/flammable material.
5.1.4. Know where the safety equipments are located and how to use
it.
5.1.5. Never pipette out corrosive material by mouth, use pipetting
bulb / mechanical pipetting devices.
5.1.6. Do not attempt to detect material by smell / taste never sniffs
reagent especially corrosive once.
5.1.7. Wash your hands after handling of chemicals and before
leaving lab.
5.1.8. Keep appropriate safety equipment readily available and
properly maintained to responds in emergencies.
5.1.9. Bare legs are not accepted when handling hot, cold, toxic and
corrosive chemicals.
5.1.10. Eyewash facilities must be readily available.
5.1.11. Know how to clean up spills of used chemicals.
5.1.12. Obey “two people” rule, second person should know that what
first person is doing.

5.2. Checklist for Preliminary hazard analysis.

5.2.1. Always check safety precaution for material you are using to
understand the specific hazard involved.
5.2.2. Review the characteristics of all reagents, reactants in terms of
flammability, toxicity and reactivity hazards where information is not
available, treat material as hazardous.
5.2.3. What is the type of Hazard? (Inhalational, ingestion, eye or skin
contact) what protective measures are required?
5.2.4. What is the recommended first aid in case of accidental
exposure?
5.2.5. Can waste be safely handled and arrangements for disposal
completed.

5.3. Safety Controls

5.3.1. Engineering controls are always the best choice for regulating
hazardous materials, use wherever applicable.
 5.3.2. Fume hoods.
5.3.3. Local exhausts hoods.

5.4. Chemical storage

5.4.1. Chemical storage should be under the supervision of qualified
person, store rooms must have adequate security.

5.5. Conduct an annual inventory

5.5.1. To remove surplus hazardous chemicals.
5.5.2. To remove chemicals that will not or has not been used in past
1-3 years.
5.5.3. To correct in compatible storage.
5.5.4. To identify which chemicals are present.
5.5.5. To conduct a regular clean up of containers and shelving.

5.6.General Rules
5.6.1. Shelving should be accessible with chemicals at eye level or
lower, no high shelf storage.
5.6.2. Avoid floor chemicals storage.
5.6.3. Do not overcrowd shelves.
5.6.4. Keep solvent containers closed. Ensure chemical container are
intact, lids are intact.
5.6.5. For emergencies have fire extinguishers of approved type
positioned near an escape route spill control and clean up materials.

5.7. Label Properly

5.7.1. Label contents clearly.
5.7.2. Labels must be intact and legible.
5.7.3. Do not overwrite labels.
 5.8. Refrigerator storage
5.8.1. In the events that chemicals need to be stored in a refrigerator
material must be secularly packed tightly and labeled.
5.8.2. Ensure that material especially those that are highly reactive or
corrosive are inspected regularly and that lids are intact.

6.0. Abbreviations
6.1. SOP- Standard Operating Procedure.
6.2. Q.C.- Quality Control.

Pilot Plant:
Pilot plants are small scale production systems used to
practically test and validate product technology before
commercialization

Lab
scale
formula
Pilot
Plant
Viable
product

Pilot plant and scale up techniques involves validation of available

equipments for production, environmental conditions, efficiency of
production before directly going to production in batch.
Pilot plant scale up is of practical interest to formulation
scientist/Production manager and should be considered from the
inception of development project. The chemical attributes of the
product, its quality and efficacy should be maintained even though the
production process modified as a result of sample size increases and
equipment changes. Pilot plant scale up in itself does not guarantee a
smooth transition.

Research & Development Production

Pilot Plant

Part of pharmaceutical industry where lab scale formula is

transformed into a viable product by developing liable and practical
procedure of manufacturing.
Objectives:

 Find mistakes in small scale. Review of processing equipment.

 To generate guidelines for production and process control.
 Evaluation and validation of process.
 Identify critical features of process.
 Provide master manufacturing formula.
 Review of chemical formula obtained from R & D.
Warehouse and storage area:
All pharmaceutical products including raw material and final
product (API’s) must be stored in compliance with requirements
specified according to each material in respective to packaging
material i;e cartons, barrels, tanks, etc. The specification provided by
quality assurance department are generated from results of stability
studies of particular product or by vendor in case of raw material. The
premise of storage area must be kept clean and must be designed
carefully as to fulfill all requirements of working area. There must be
two different gates for entry and exit of products. The weighing
machine must kept at starting of entry gate of material.
Following Parameters must be checked for Warehouse Area:
1. Size/Area- Must be sufficient to store different categories of
products separately. (Liquid, Solid)
2. Storage conditions:- The factors such as temperature, relative
humidity, etc must be kept to optimum limit and monitored
periodically.
3. Cleanliness- Must be cleaned regularly to avoid contamination
in material of interest. Equipments to arrest rodents must be
placed in storage area. Spillage should must be avoided or
cleaned immediately.
4. Sampling area- there must be separate cell for sampling of
material. The cell is kept in roughly aseptic conditions, there
must be small gowning area.
5. Entry and Exit documentation- The product release must be
done after clearance from QA department.
General indications about Product:

 Label- The labeling includes the product name, manufacturing

date, manufacturer details, etc.
 Ropes and Net cloth-

Product in Package
(Blisters, Containers,Vials, Cartons,Boxes.)

Tied with yellow rope, blue net. Tied in Green rope.

NOT APPROVED APPROVED